FDA Panel Considers HIV Drug For New Use

Advisers to Weigh Pros, Cons of a $14,000-a-Year Drug for Use in People at High Risk of Getting Virus That Causes AIDS

By

Jennifer Corbett Dooren

May 6, 2012 8:19 p.m. ET

A Food and Drug Administration advisory panel this week will decide whether to recommend for the first time that certain healthy but at-risk people take a drug to help prevent them from contracting the virus that causes AIDS.

Approval by the agency would mark another milestone in the three-decade effort to combat HIV and AIDS. Huge advances in drugs to treat infection and its symptoms have allowed patients to live significantly longer and healthier lives for a disease that in the 1980s was a death sentence.

On Thursday, an FDA panel will weigh whether Gilead Sciences Inc., which makes the HIV treatment drug Truvada, should be allowed to market the drug to help prevent high-risk patients from contracting HIV in the first place. It is the first time a company has asked the FDA for approval of an HIV drug as a prevention tool.

The FDA doesn't comment on pending drug applications, and there is too much disagreement over the drug studies to predict whether the agency will sign off on the new use. The FDA doesn't have to follow the recommendations of its expert panels, but usually does.

Some research has shown that taking the drug can materially lower a person's risk of HIV infection and most doctors support using it this way in limited circumstances. Truvada—a combination of two medicines that makes it harder for HIV to multiply in the body—is one of the most widely used HIV drugs. It costs about $14,000 a year.

But medical experts and AIDS activists are divided over whether the agency should approve Gilead's application.

Some doctors argue the clinical data aren't strong enough and that approval could undermine other HIV prevention efforts like condom use. Others fear an FDA rejection might stall additional research into new HIV-prevention efforts.

ENLARGE

The AIDS Healthcare Foundation is leading efforts against FDA approval of Truvada. The organization filed a petition with FDA in March urging the FDA to reject the application, saying the data weren't strong enough to show the drug prevents HIV in healthy people.

The group also cited concerns about drug side-effects, the estimated annual cost of the drug, and the difficulty of sticking with a daily pill regimen.

But another organization, called AVAC, a group that advocates for HIV prevention methods, is leading efforts in support of Truvada, and was among 14 organizations that last week submitted a letter the FDA urging approval.

"This is the first of what we'd hope would be many interventions," said Mitchell Warren, AVAC's executive director. "The ultimate is a vaccine."

Data from two large clinical trials were submitted by Gilead in support of using Truvada for pre-exposure prophylaxis, or "PrEP." A study funded by the National Institutes of Health, which involved about 2,500 gay or bisexual men at high risk of contracting HIV, showed the drug cut the risk of contracting the virus by 44% in addition to other prevention methods like condom use compared with those taking a placebo pill.

The other study, conducted by the University of Washington and funded by the Bill and Melinda Gates Foundation, involves about 4,800 heterosexual couples in Uganda and Kenya in which one person was infected with HIV and the other was not. Interim data released last year showed HIV-negative partners who were taking Truvada had a 73% reduced risk of becoming infected with HIV compared with those in the placebo group.

Truvada "is the first new modality that has a chance of moving the needle" for preventing new HIV infections, said Howard Jaffe, president of the Gilead Foundation, a philanthropic arm of the company to which Gilead referred questions on the drug.

But other studies on women haven't shown the same benefit. A study involving about 2,000 women in Africa was stopped last year after an independent monitoring committee decided it was unlikely to show Truvada helped prevent HIV infection in women.

Dr. Rodney Wright, the chairman of the board of the AIDS Healthcare Foundation and the director of HIV programs at Montefiore Medical Center in Bronx, N.Y., says he is concerned about Truvada getting "a blanket approval" as a prevention tool. He is worried about the lack of data on women and thinks other types of medicines could be more promising in preventing infection with HIV.

Physicians on both sides of the issue, including Dr. Wright, already use Truvada as a prevention tool in limited circumstances, such as when heterosexual couples with one HIV-positive partner want to try to conceive a child.

Last year, the Centers for Disease Control and Prevention issued interim guidelines for using Truvada as a prevention tool for some gay and bisexual men. The CDC is working on similar guidelines for heterosexuals.

"PrEP will be the most beneficial for people at very high risk of HIV infection," says Jonathan Mermin, the director of CDC's Division of HIV/AIDS prevention. But research shows it's essential that people adhere to the drug's daily dose regimen in order for it to work, he said.

In the U.S., about 1.2 million people are infected with HIV and about 50,000 new infections are diagnosed each year.

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